1. Field of the Invention
The invention is directed to a device for sealing, or occluding, an opening of the large intestine (colon), or rectum, of a patient, and, as appropriate, for continuously and/or intermittently draining, or removing, stool therefrom, preferably into an external, bag-like collection container, the device comprising an inflatable balloon with an generally annular structure formed from a flat, everted tube section, wherein the outer layer of the everted tube section is provided with a radially enlarged region (intrarectal balloon portion) for insertion into the rectum and is provided with a region that is tapered relative thereto (transanal balloon portion) and that remains at least regionally outside the rectum during use.
2. Description of the Prior Art
Devices for continuously draining, or intermittently removing, stool from the large intestine (colon), or rectum, of a patient into an external, bag-like collection container, particularly also by means of a rectally administered enema of irrigation fluid, are known.
Drainage, or collection, of stool in the case of immobile, uncooperative patients is preferably carried out with the aid of so-called fecal collectors. These are bag-like structures that are adhesively attached in the anal fold just above the anal opening. Although preanal adhesive attachment is usually sufficiently stable and leaktight for short periods of use, maceration of the exposed skin surfaces is often observed as a result of the continuously moist and chemically aggressive medium in the adhesion area.
An alternative is the use of so-called intestinal tubes, which are inserted through the anal canal into the rectum. Due to the accompanying risk of intrarectal injury, as well as the permanent dilation, and thus the potential for damage to the sphincter muscle, intestinal tubes are normally used for stool drainage only on a temporary basis.
Systems for largely atraumatic stool drainage that can be used over a long term (indwelling fecal drainage), of the kind recently introduced by Zassi Medical Evolutions Inc., Florida, USA, and ConvaTec, New Jersey, USA, are structurally similar in design to balloon catheters for the continuous drainage of urine. Urine is drained from the bladder via a balloon-equipped catheter element, and flows through a connected drainage tube into a collection bag. The balloon element in this case is used primarily to anchor the catheter in the bladder. It also performs a sealing function to some extent, preventing urine from flowing down through the urethra past the shaft of the catheter. Analogously, the known stool drainage systems include a balloon-equipped head portion that anchors the device, collects the stool, and conducts it away, and, connected to this, a tube element that debouches into a collection container.
Modern stool drainage systems, such as the aforesaid, also serve, in addition to the drainage function per se, the purpose of actively managing fecal excretion of the patient within the context of stool management (fecal/bowel management) by therapists.
The concept of stool management includes the option of relatively high-volume or large-volume colorectal irrigation via the anus. Large-volume enemas into the colon have been used for active excretion management in patients with surgically created colostomies. The irrigation fluid injected into the colon mobilizes the contents of the bowel and stimulates intestinal peristalsis, thus causing the colon to largely empty in a manner that is initiated, or triggered, by the user.
Similarly, the contents of the bowel in immobile, uncooperative, bedridden patients can be mobilized and drained by large-volume transanal enema. Defecation is thereby monitored and managed by a therapist. A stool-free, virtually continent interval of one to two days can be achieved in this way.
Colorectal enemas (so-called colorectal irrigation) have been used in clinical practice heretofore primarily to mobilize the stool in the presence of constipation or bowel voiding dysfunction.
The principle of colorectal irrigation has been used successfully in mobile, independent, incontinent patients who, for a wide variety of reasons, have lost ability to evacuate the bowels (defecate) under deliberate control. In these patients, the volume of fluid irrigated into the rectum or colon via the anus has the effect of stimulating intestinal peristalsis, with the objective of emptying the large intestine as completely as possible. The result, for the patient, is a stool-free interval during which there is no possibility of uncontrolled passage of stool through the anus, despite manifest insufficiency of the anal sphincter. Crucial to adequate irrigation is that the injected volume must both mobilize stool in the colon and trigger peristalsis or the defecation reflex. The instillation of the enema solution is usually followed by an interval of several minutes during which the large intestine remains quiet, until peristaltic contractions finally set in and the colon or rectum begins to expel the contents of the bowel. To ensure that the necessary enema volume is retained in the bowel until reflexive expulsion begins, transanally introduced irrigation apparatuses are often equipped with a sealing element. This is usually in the form of a tightly filled balloon that is placed in the terminal rectum; the balloon is mounted on a tube-like inserting element and is designed to keep irrigation fluid from exiting the anus during the waiting period before colonic peristalsis begins.